Vascular Endothelial Protection Effects of Dextromethorphan - Full Text View

Sponsored by:	National Cheng-Kung University Hospital
Information provided by:	National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:	NCT00605605

Purpose

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.

Condition	Intervention	Phase
Atherosclerosis Smoking Inflammation	Drug: Dextromethorphan	Phase IV

MedlinePlus related topics: Smoking

Drug Information available for: Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:

Endothelial function [ Time Frame: 1, 2, 3 and 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa [ Time Frame: 1, 2, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	March 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dextromethorphan 120 mg/day, single once daily dose taken after breakfast by oral route

Detailed Description:

Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear.

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

healthy male volunteers who are currently smoking

Exclusion Criteria:

personal history of hypertension or diabetes mellitus
family history with
documented premature cardiovascular events
cardiovascular-associated sudden death
total cholesterol > 240 mg/dL
triglyceride > 200 mg/dL
low-density lipoprotein > 160 mg/dL.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605605

Locations

Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

Principal Investigator:

Ping-Yen Liu, MD, PhD

Assiatant Professor of National Cheng Kung University Medical Center

More Information

Responsible Party:	National Cheng-Kung University Medical Center ( Ping-Yen Liu/ Assitant Professor )
Study ID Numbers:	HR-93-28, 91-B-FA09-2-4 grant number
Study First Received:	January 18, 2008
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00605605
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:

endothelial function
atherosclerosis
smoking
inflammation
antioxidant

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Excitatory Amino Acids
Vascular Diseases
Arteriosclerosis
Inflammation
Naphazoline

Smoking
Oxymetazoline
Phenylephrine
Guaifenesin
Dextromethorphan
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Agents
Pharmacologic Actions
Habits

Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Antitussive Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 14, 2009